Hello, my name is Ted
Vallejos.† Thank you for taking the time
to listen to me.† I am here today with
the help of the Asthma and Allergy Foundation of America, but my comments are
on my own behalf.† I hope that after
listening to my history and experience with Xolair, this will help you make the
decision to approve this new and amazing medicine.† Throughout my adult life and the majority of
my childhood, I have never experienced the freedom from asthma that I did for
the short time I was on Xolair.

At the age of 7, I aspirated a
silver tip of one of those old, black government/military pens and my life with
asthma began.† Since then, I have had ER
visit after ER visit and hospital admission after hospital admission.† My medical chart is the size of a large phone
book.†† At the age of 13, my doctor told
my parents that due to my asthma, we had to leave Hawaii.† Of course, my brothers and sisters were not
very happy.

Iím currently 38 years old,
married, living in the sunshine, and working as a Respiratory Therapist in San
Diego.† The move to San Diego definitely
decreased my ER visits and hospital admissions.†
From the ages of 7 to 24, I was admitted to the hospital about seven or
eight times.† In 1989óat the age of 25óI
was intubated for the first time.†† I was
again intubated in 1991.† Another ICU
admission followed a year later.

In 1994, a co-worker recommended I
consult with Dr. Eli Meltzer who helped me gain control of my asthma.† I have not been intubated, hospitalized, or
gone to the ER since, but I always had to worry about wheezing and shortness of
breath.† Prior to seeing Dr. Meltzer in
í94, I was wheezing daily and awakening almost every night from my asthma
attacks.† I had to sleep with a nebulizer
at my bedside.† My upper airway was
always mildly stuffy.† My medications
included Uniphyl 1200mg QD, Azmacort 4 puffs BID, Intal 4 puffs BID, using my
albuterol inhaler 6-16 times a day (about a canister a month), and Prednisone
bursts about 4-6 times a year.† Dr
Meltzer changed my regimen to albuterol nebulizers BID, Serevent BID, Uniphyl
1200mg QD, Aerobid 4 puffs BID (now on 4 puffs Flovent 220mc), albuterol MDI
PRN, 20mg Prednisone QD (for about 4 months then changed to QOD), and Claritin
(but now Allegra).† This new regimen
helped reduce my wheezing and cut my prednisone bursts to once or twice a year.† For almost two years I tried
allergy-desensitizing shots with no success.†
I could not get out of the first phase because my wheezing would flare
up.† I have also been taking Prilosec for
my stomach pains and gastric reflux.† I
have tried Accolate (and now Singulair).†
Singulair has helped my symptoms a little and I have been weaned from my
prednisone dose from 20mg QOD to about 10mg QOD.

Approximately two summers ago, I
volunteered for the Xolair clinical research study.† By the middle of the trial, I was feeling and
breathing really well.† My wheezing would
rarely flare up and my nose was not as stuffy.†
In fact, by the end of the trial I was exercising on a regular
basis.† My breathing was so strong I
started jogging.† Until that time, I had
never been able to run continuously for more than a mile in my 38 years.

Fortunately, I was able to receive
Xolair for an additional three months after the trial.† During that time, I was able to take myself
off of Prednisone and the 1200mg of Uniphyl.†
I was also able to decrease my Flovent usage from 4 to 2-3 puffs each
day.† My PFTs showed improvementómy FVC
increased from the mid 80s to the mid 90s, my FEV1 went from the mid
60s to the mid 70s, and my FEF25-75 increased from the low to mid 30s to the
mid 40s.† My IgE blood level had dropped.

It was the best I had felt in a
long, long time.† I ran my first 5k run
without stopping to walk.† A month later,
I ran another.† It was amazing.† I had my inhaler with me, but didnít need to
use it.† During the last two months on
Xolair and even for a couple of months after, I was able to leave the house
without my inhaler in my pocket.† This
was something I had never experienced before!†
Never in my life did I think I could leave home without it!

Unfortunately, it has been a little
over a year since my last injection of Xolair.†
My asthma, wheezing, shortness of breath, stuffy nose, and having to
have an inhaler in my pocket at all times has gradually returned.† I actually still feel better than I did prior
to the study.† In fact, although I had
never been able to participate directly in sports growing up, thanks to the
benefits of Xolair I joined a softball team.†
My team is 7 and 1 and heading into the playoffs and Iím actually
missing a game to be here with you today.

Iím currently in the middle of my
second softball season and it is getting more difficult to run those
bases.† I tighten up very easily.† I can no longer jog or run for pleasure.† And, although Iím still off the prednisone,
Iím back to 4 puffs of the Flovent, back on a little bit of Uniphyl (400mg),
and Allegra (these along with the others I mentioned earlieróSingulair,
Serevent, and Prilosec).

Another nice thing about Xolair was
that it didnít give me the typical side effects like tremors, like the feeling
of your heart pounding out of your chest, stomach pains, nausea, hunger,
feeling tired, or my face looking like a moon (just to mention a few).†

I believe that if I could continue
with Xolair, I could maybe get by with only the maintenance drugs Flovent and
Serevent.† Perhaps someday I might get by
with just Xolair.

Iím not sure.† But I am sure that I could definitely live
the rest of my life free of asthma.†

I hope that my testimony here today
helps you with your decision to approve Xolair for the difference it has made
in my life and for so many others with allergic asthma.